BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 9597144 · Received January 16, 2020

    Report

    Report Number
    2031642-2020-00199
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    January 7, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 01/16/2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TOUCHSCREEN UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CLEANED AND CALIBRATED THE TOUCHSCREEN TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62426 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1